Dr. Jerry R. Clark In Ovation X White Paper (PDF)

In-Ovation X

A Story of Design, Development and Ingenuity
White Paper by
Jerry R. Clark, DDS, MS
Greensboro, NC

Jerry R. Clark, DDS, MS

is a board certified orthodontist who
has practiced in Greensboro, North
Carolina for over 40 years. For over
35 years he has lectured throughout
the world on numerous topics related
to the practice of orthodontics and he
has published over 50 articles. He also
founded Orthodontic Management
Group which is now Bentson Clark and
Copple the leading company involved
in orthodontic practice transition.
Dr. Clark was honored in 2017 by
the AAO, receiving the prestigious
Humanitarian Award for his service to
the profesion and mankind

In-Ovation X
A Story of Design,
Development
and Ingenuity
by Dr. Jerry Clark

Introduction
Since the introduction of the In-Ovation R bracket
over a decade ago, other manufacturers have been
unsuccessful in their attempts to improve on its
form, fit, and functionality until now.
Dentsply Sirona Orthodontics, the leader in
orthodontic brackets, has taken a quantum leap
forward with the new In-Ovation X bracket system.
The project started with GAC assembling a group
of noted orthodontists throughout the world to
meet in Philadelphia, Pennsylvania, their task was
to define clinical design inputs for the “ultimate
orthodontic bracket”. The result was the In-Ovation
X orthodontic bracket system.

The Story of In-Ovation X
That first meeting in Philadelphia, Pennsylvania
was an organized collaborative effort to design
an orthodontic bracket. The doctors attending
this meeting included: myself, Antonino Secchi,
Celestino Norbrega, Luis Nunez, Julia Garcia-Baeza,
Ryan Tamburrino, Shalin Shah, Dan Fishel, Raffaele
Spena, and Sam King (short biographies on these
key contributors can be found in the appendix
section towards the end of this paper). Critical to the
design process were the members of the Dentsply
Sirona Orthodontics Marketing and Research and
Development Teams. For two days this group
discussed the pros and cons of traditional edgewise
verses self-ligating brackets, the design features of
all the brackets presently available in the market
place, the strong points and weaknesses of each
of the brackets, and identified the characteristics
that would be present in the “ultimate bracket”. It
was unanimously decided that self-ligation was the
bracket design of choice.
The members of the Marketing and Research and
Development Teams presented numerous design
concepts for the “new” ultimate orthodontic bracket.
The meeting was recorded, copious notes were
taken, and all input was recorded and assimilated by
the Research and Development Team to be used in
designing the new bracket. This was the first time
in my experience, such an exhaustive collaborative
process had been utilized in the design of an
orthodontic bracket. Less than a month later the
team of doctors reconvened in New York to see the
prototype that teams had developed. The doctors
were amazed. In a short period of time the design
engineers at Dentsply Sirona Orthodontics were
90% of the way finished with the bracket design.
Several small suggestions and changes were then
incorporated into the final design and In-Ovation X
bracket was born.

The challenge then was to figure out how to
manufacture the brackets since no off-the
shelf machinery existed that could produce an
orthodontic bracket to the tolerances desired by
Dentsply Sirona Orthodontics.
The company’s vision in making this considerable
investment was to re-invent the way orthodontic
brackets are manufactured in order to significantly
improve the quality, precision, and accuracy of the
finished orthodontic bracket. In order to manufacture these state of the art brackets, a brand new
wing was added to the high-tech manufacturing
facility in Sarasota, Florida. The production team
customized manufacturing robots and developed
processes that enabled them to produce orthodontic
brackets with a degree of quality, precision, and
accuracy never before attained in this industry.
Dentsply Sirona Orthodontics didn’t stop there. They
believed that in order to ensure the bracket was
everything it was designed to be, clinical trials were
initiated to prove the design concept. And now, after
over 2 years of successful clinical trials the bracket is
available for introduction into the marketplace.

The Manufacturing Process
With the release of the In-Ovation X bracket,
Dentsply Sirona Orthodontics has revolutionized
the way orthodontic appliances are manufactured.
They have done this through the development
and utilization of flexible robotic assembly
systems and customized upstream manufacturing
processes. This state of the art facility utilizes metal
injection molding technologies as well as custom
manufactured robotic systems with in-process
vision inspection to build orthodontic brackets
with precision and quality assurance unmatched in
the industry. These robotic systems are capable of
assembling the brackets to a 20 micron tolerance
and then automatically inspect them to ensure
they are within those tolerances before they leave
the manufacturing station. From the raw materials
to finished assemblies, the brackets are precisely
formed, assembled, welded, polished and inspected
using the most advanced automated technology
available. No other orthodontic bracket available
on the market today is produced with this degree of
quality, precision and accuracy. In my assessment,
the ingenious design of the bracket combined with
the state of the art manufacturing process, will
ensure a better treatment experience for both the
patient and the clinician.

Traditional Edgewise Brackets vs. Self-ligating Brackets –
A Brief Review of the Literature
Over the past 20 years a tremendous amount of
research has been published in orthodontic journals
about self-ligating brackets and the purported
benefits in improving the efficiency of orthodontic
treatment. Exhaustive studies have been conducted
comparing virtually every aspect of the treatment
of cases with traditional edgewise brackets versus
self-ligating brackets5,6,7,8,19,21,22,23,24,26,27,28,29,30,33,34,40.
Length of treatment time, number of patient
visits, patient chair-time, and other treatment
parameters have been examined and reported on
in the literature. Many other studies8,9,10,12,38 have
compared friction, binding and the sliding abilities of
self-ligating brackets when compared to traditional
edgewise brackets.
The surprising results of all these studies are that
there is really no industry consensus on which type
of bracket will provide the best treatment for our
patients. Many studies come to the conclusion
that self-ligating brackets offer “no benefits” to
the patient. Other studies show that there is less
friction and binding, patient discomfort is reduced,
teeth do move faster, treatment is completed faster,
less chair-time is needed, and fewer appointments
are necessary for the successful completion of an
orthodontic case. In the bibliography of this White
Paper Report I have listed many articles addressing
this very question, “Are there any real treatment
benefits that would justify the use of self-ligating
brackets?” I urge the reader examine these articles
and draw their own conclusions. Over the upcoming
years I am sure many more studies will be performed
and eventually we will have a clearer understanding
of the true benefits of self-ligating brackets.

Appointments

9.6 vs 16.26
In-Ovation averages 40% fewer
appointments than traditional
brackets with ties.

Because of the diverse findings and the vast
differences of opinion, several years ago I decided
to do a study of my own to try to determine if, in my
practice, I noticed any real benefits to the utilization
of self-ligating brackets. I decided to compare cases
in my practice that were treated using traditional
edgewise brackets with cases that were treated
using In-Ovation R brackets. It was a simple study
that compared three parameters of treatment:
• Number of appointments necessary to complete
treatment
• Amount of chair-time required to complete
treatment
• Length of treatment
This study was later published as a White Paper
Report entitled, “Increasing Practice Efficiency
and Profitability Utilizing In-Ovation Self-Ligating
Brackets” and is available from the Dentsply Sirona
website at: https://www.dentsply.com/content/dam/
dentsply/pim/manufacturer/Orthodontics/Brackets/
Self_Ligating/In_Ovation_R/In_Ovation_R/120-08904-r2-WP-Clark-qn8qvxd-en-1412.pdf
In short, the use of self-ligating brackets in my
practice resulted in 40% fewer appointments, up to 3
less hours of chair time per patient, and a reduction
of 4.14 months of active treatment time. This report
was also published in Ortho-The International C.E.
Magazine of Orthodontics Vol.3 – Issue 1/2014 under
the same title.

Time

302.55 minutes vs 476.76 minutes
With In-Ovation* doctors realize
a chairside time savings of
approximately 3 hours per patient.

Months in Treatment

19.83 months vs 23.97 months
In-Ovation finishes equivalent cases
approximately 4 months sooner
than traditional brackets with ties.

*Jerry R. Clark, DDS, MS, Jack Gebbie, BS, Datatex Market Research Report Summary: Increasing Practice Efficiency and Profitability Using In-Ovation Self-Ligating Brackets, March, 2007. Datatex is a member of CASRO® Council of American Survey Research Organizations

Incontrovertible Benefits of Self-Ligation
Elimination of “round tripping” of teeth
As was documented in the literature on numerous
occasions by: Sherruff8, Pizzoni9, Heano and Kusy10,
Parkin12 and many others, teeth are freer to slide on
self-ligating brackets thereby creating significantly
less binding and friction as the teeth move. When
bringing in a high canine the wire can easily slide
through the canine bracket as well as the bicuspids
and molars thereby allowing the tooth to move
occlusally without protruding the incisors.
Quicker archwire changes
It takes far less time to change archwires when using
self-ligating brackets. The bracket door or clip is
opened, the old wire is removed and the new wire is
placed and the door or clip is closed. Some studies
indicate a time savings of 7 minutes or more when
self-ligating brackets are used as compared to using
traditional brackets and ligating with metal or elastic
ties.
Consistency of archwire engagement
Every self-ligating bracket, no matter whether the
doctor or assistant engages the archwire in the
bracket, produces a consistent amount of force on
the tooth thus producing more predictable tooth
movement. With steel or elastic ties there can be
an inconsistency of force on the tooth after the wire
is engaged in the bracket depending upon who is
engaging (tying) the wire into the bracket and the
method of engagement.

Security of archwire engagement
With traditional edgewise brackets if an elastic chain
breaks, or an elastic tie comes off the tooth or a
metal tie is loose and not properly securing the wire
into the bracket sometimes significant undesirable
tooth movement can occur. This does not occur
with self-ligating brackets since once the door or clip
is closed the archwire is secured into the bracket.
Fewer emergency visits for patients
Since the archwire is securely engaged in the self-ligating bracket, broken elastic ties or chains have
no effect on the engagement of the wire into the
bracket and therefore adverse tooth movement will
not occur, thus eliminating the need for additional
emergency visits to the office to replace them or
tuck in protruding ligature ties that are sticking the
patient.
Less discomfort for the patient
In a study published in Clinical Impressions entitled
“Orthodontics from Good to Great” Dr. Derick
Tagawa states, “The average pain-level response
from patients with conventional brackets was 4
(pain was measured with 0 being no pain and 10
being severe pain) while the average pain-level from
the Damon System patients with the self-ligating
brackets was 1.3 with no pain reported higher than
415”.

Other Potential Benefits of Self-Ligation
Reduction of root resorption
Several studies indicate that the use of lighter forces
and the elimination of “round tripping of teeth” may
reduce the amount of root resorption experienced
during orthodontic treatment, although other studies
maintain this advantage is still up for debate31,36,
more studies need to be done.
Fewer patient appointments are necessary to
complete treatment
Another potentially significant benefit for the patient
is the reduction in the number of visits necessary to
complete treatment when self-ligating brackets are
used. Although there are some studies that indicate
no time savings, reduced patient visits, or shorter
treatment time, there are numerous published
articles documenting that the use of self-ligating
brackets does reduce the number of patient visits
necessary to complete treatment .
Reduced chair-time to complete treatment
Another possible significant benefit of self-ligating
brackets is the reduced chair-time necessary to
complete treatment. Some studies demonstrate
a reduction in patient chair-time up to 30% AND
appointments can be shorter due to the efficiency of
quicker archwire changes .

Reduced treatment time
There are many conflicting research studies
concerning the reduction of treatment time when
self-ligating brackets are utilized. Some studies
indicate a time saving of up to 5 months5,6. Other
studies show no reduction in treatment time. Since
self-ligating brackets are in essence edgewise
brackets with a clip or a door, all should be able to
agree that treatment should NEVER take longer
when utilizing self-ligating brackets.
Increased practice profitability
If any time is saved in treating patients then that
saving can impact the practice’s bottom line. Noted
and respected orthodontic practice consultant Mary
Beth Kirkpatrick states the following: “Practices that
consistently used self-ligating brackets for one year
or more report the following:
• Collections/Production per doctor hour
INCREASES
• Cost to complete treatment per patient
DECREASES
• Schedule is less stressful for doctor, staff and
patients
• Patients are pleased to complete treatment in less
time
• Treatment Efficiency and profit per patient
INCREASES

“Treatment efficiency is directly related to
the number of visits. A commonly used
measure of efficiency is to divide the
treatment fee by the number of visits. With
fewer visits, a practice whose efficiency
quotient was previously $240 per visit is
now reporting that value to be upward of
$350 per visit.”
Mary Beth Kirkpatrick